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Policies for biosimilar uptake in Europe: An overview

E. Moorkens, AG. Vulto, I. Huys, P. Dylst, B. Godman, S. Keuerleber, B. Claus, M. Dimitrova, G. Petrova, L. Sović-Brkičić, J. Slabý, R. Šebesta, O. Laius, A. Karr, M. Beck, JE. Martikainen, GW. Selke, S. Spillane, L. McCullagh, G. Trifirò, P....

. 2017 ; 12 (12) : e0190147. [pub] 20171228

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc18010220

BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. RESULTS: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. CONCLUSIONS: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Ljubljana Slovenia

Barcelona Health Region Catalan Health Service Barcelona Spain

Croatian Health Insurance Fund Zagreb Croatia

Department of Biomedical and Dental Sciences and Morphofunctional Imaging University of Messina Messina Italy

Department of Laboratory Medicine Karolinska Institutet Stockholm Sweden Strathclyde Institute for Pharmacy and Biomedical Sciences University of Strathclyde Glasgow United Kingdom

Department of Medicines and Medical Devices The National Health Service Riga Latvia

Department of Pharmacology and Therapeutics Trinity College Dublin Dublin Ireland National Centre for Pharmacoeconomics St James's Hospital Dublin Ireland

Division Pharmaceuticals Norwegian Hospital Procurement Trust Oslo Norway

Faculty of pharmaceutical sciences Ghent University Ghent Belgium

Faculty of Pharmacy Medical University of Sofia Sofia Bulgaria

Faculty of Pharmacy University of Lisbon Lisbon Portugal

Health Insurance Institute Ljubljana Slovenia

Hospital Pharmacy Erasmus University Medical Center Rotterdam The Netherlands

HTA Consulting Cracow Poland

Karr Consultancy Ltd Hertfordshire United Kingdom

KU Leuven Department of Pharmaceutical and Pharmacological Sciences Leuven Belgium

KU Leuven Department of Pharmaceutical and Pharmacological Sciences Leuven Belgium Medicines for Europe Brussels Belgium

Main Association of Austrian Social Security Institutions Vienna Austria

Ministry of Welfare Reykjavik Iceland

OMEDIT Alsace Agence Régionale de Santé du Grand Est Strasbourg France

Primary healthcare center Zemun Belgrade Serbia

Research Unit Social Insurance Institution Helsinki Finland

Semashko National Research Institute for Public Health Moscow Russia

State Agency of Medicines Tartu Estonia Department of Traumatology and Orthopedics University of Tartu Tartu Estonia

State Institute for Drug Control Brno Czech Republic

State Institute for Drug Control Prague Czech Republic

Strathclyde Institute for Pharmacy and Biomedical Sciences University of Strathclyde Glasgow United Kingdom

TLV Stockholm Sweden

Wissenschaftliches Institut der AOK Berlin Germany

Citace poskytuje Crossref.org

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$a BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. RESULTS: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. CONCLUSIONS: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.
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